FDA, NIH announce new partnership
WASHINGTON The Food and Drug Administration and the National Institutes of Health hope to accelerate the availability of medical products for patients under an initiative announced Wednesday.
The two organizations said they aimed to use translational science –– the shaping of basic scientific discoveries into treatments –– and regulatory science to more efficiently develop products and effectively evaluate product safety, efficacy and quality.
Part of the effort will involve creating a joint NIH-FDA leadership council to ensure that regulatory considerations are included in biomedical research planning and that the latest science is integrated into the regulatory review process.
“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” Health and Human Services secretary Kathleen Sebelius said in a statement. “However, much more can be done to speed the process from new scientific discoveries to treatments for patients.”
The organizations plan to have a public meeting in the spring to solicit input on how they can collaborate.
Alliance Health Networks forms healthcare advisory board
SALT LAKE CITY Alliance Health Networks, which is building a universe of social health networks focused on such specific health conditions as diabetes, has formed a healthcare advisory board. Among the founding members: pharmacy industry veteran Gordon Barker.
According to Alliance Health’s CEO, Stead Burwell, the advisory board is designed to provide Alliance Health executive management and its board of directors with industry insights, feedback and strategic counsel in support of its efforts to build online social health networks that bring together patients, caregivers and industry participants.
Alliance Health’s first social health network DiabeticConnect.com, has attracted the largest online population of people living with or treating diabetes, according to the company.
Barker has a nearly 40-year career in the pharmacy industry that includes 30 years with Thrifty PayLess Drug Stores, now Rite Aid. He started there as a pharmacist and eventually became president and CEO. He then served as CEO of Snyder Drug from 2005 through early 2009. In addition, Barker served as chairman of the board of the Juvenile Diabetes Research Found and currently serves on its board of chancellors.
Additional members of the advisory board include McKesson veteran, Richard Hawkins; and Robert Johnson, former chairman and CEO of PCS Health Systems, which is now part of CVS Caremark.
Inhaled CF antibiotic receives FDA approval
BETHESDA, Md. The Food and Drug Administration has approved the first inhaled antibiotic for cystic fibrosis in more than a decade, according to a cystic fibrosis advocacy organization.
The Cystic Fibrosis Foundation announced the FDA’s approval of Cayston (aztreonam), developed by Gilead Sciences. The organization invested $1 million to help development of the drug.
“The approval of Cayston demonstrates that our drug-development model is working and making a real difference in the lives of people with cystic fibrosis,” Cystic Fibrosis Foundation president and CEO Robert Beall said in a statement. “We are delighted to have a new antibiotic in the arsenal to help fight the life-threatening infections associated with this disease, as we continue to push forward with other therapies that address the underlying cause of CF.”